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Rekambys (rilpivirine) and Vocabria injection (cabotegravir) First long-acting injectable antiretroviral therapy for HIV
21 October 2020
EMA has recommended the granting of marketing authorisations for two new antiretroviral (ARV) medicines, Rekambys (rilpivirine) and Vocabria injection (cabotegravir), to be used together for the treatment of patients with human immunodeficiency virus type 1 (HIV-1) infection. The two medicines are…
Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) first FDA approved treatment for Ebola virus
15 October 2020
The U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. “Today’s action demonstrates the FDA’s…
Opdivo (nivolumab) in combination with Yervoy (ipilimumab) newly approved first-line treatment of adults with malignant pleural mesothelioma.
5 October 2020
The U.S. Food and Drug Administration has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the…
Jyseleca (filgotinib), approved in the EU for the treatment of adults with moderate to severe rheumatoid arthritis
2 October 2020
Jyseleca is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease in which the immune system (the body’s natural defences) attacks healthy tissue to cause inflammation and pain in joints. Jyseleca is used alone or with another medicine, methotrexate, after treatment…
Nucala (mepolizumab), First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years
27 September 2020
The Food and Drug Administration has approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease. The new indication for Nucala is the first approval…
Velphoro (sucroferric oxyhydroxide) has been approved for the treatment of children with chronic kidney disease
21 September 2020
EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children aged 2 years or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis. Patients with severe kidney disease cannot eliminate…
New indication for Olumiant (baricitinib) as oral treatment for moderate to severe atopic dermatitis
18 September 2020
EMA has recommended granting an extension of indication to Olumiant (baricitinib) to include the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. Olumiant is already approved in the European Union to treat moderate to severe active…
Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test
29 August 2020
Roche has announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours. FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyses more…
Vaginal ring to reduce the risk of HIV infection for women in non-EU countries with high disease burden
14 August 2020
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis (PrEP) is not used,…